1. Field of the Invention
The present invention generally relates to medical devices, and more specifically relates to packages for medical devices.
2. Description of the Related Art
Medical devices are typically stored in sterile packages prior to being removed from the packages for use during surgical procedures. For example, U.S. Pat. No. 7,600,634 to Malinowski et al. discloses a package for sutures including an envelope, an outer jacket, and an inner retainer that is secured within the outer jacket. The envelope receives the outer jacket and the inner retainer when the outer jacket and the inner retainer are folded. The envelope has a top sheet formed of a clear plastic, such as a polyethylene, and a bottom sheet constructed from paperboard, fiberboard, Tyvek®, aluminum foil or other similar materials. The combination of materials of the top and bottom sheets prevents or impedes the transmission of moisture therethrough. The top sheet and the bottom sheet are generally rectangular in shape, are substantially the same size, and are adhered together along their respective peripheries by an adhesive material.
Commonly assigned U.S. Pat. No. 6,533,112 to Warnecke discloses packaging for surgical sutures having a base with a raised edge and a spiral-like thread duct that opens at a first end thereof to a thread removal zone defined by a recess in the base located adjacent the first end of the thread duct. The base includes a thread tray positioned on an opposite side of the recess from the first end of the thread duct, and a thread holder having a nose extending inwardly from the raised edge of the base above the thread tray. The packaging includes a cover applied to the base above the thread dud. In one embodiment, the cover is made from a piece of cardboard that is coated on its underside with polyethylene. The cardboard cover is suitable for imprinting so that packaging can be easily provided with a product label. In addition, the cardboard cover is adapted to absorb residual quantities of water after a package with surgical suture material has been introduced into an outer wrapper. The cardboard cover also protects the surgical suture material and acts as a lid for the base to reinforce the entire package.
U.S. Pat. No. 5,699,909 to Foster discloses a surgical instrument package including an outer envelope having first and second sheets of microorganism-impervious material that are bonded together around the periphery of each sheet, and a retainer member insertable within the outer envelope for holding a medical product. The retainer member includes a strip of flexible material such as polyethylene terephthalate, polyethylene, vinyl, polypropylene and ethylene vinyl acetate.
In spite of the above advances, there remains a need for a package for medical devices, such as tissue supporting implants, which has enhanced integrity and functionality so that surgical personnel may easily remove and control the medical device as it is removed from the package. There also remains a need for a package for dispensing medical devices that securely locks so that the medical devices do not easily spill out of the packaging when the package is opened. In addition, there is a need for medical packaging which does not require additional adhesive to secure the packaging and the medical products, thereby reducing the bio-burden and the possibility of adhesive leaching into the medical device. There also remains a need for a medical package dispenser whereby a medical device can be inserted into the package during a folding and/or tucking operation, which allows for easy filling of the package without risking folds or bends in the medical device and without risking the medical device catching a surface of the dispenser package during removal of the medical device from the package. There also remains a need for medical packaging that prevents unwanted drops or mishandling, and that allows for easy access and dispensing of the medical product. There also remains a need for medical packaging whereby the product is covered and protected in a sterile environment until immediately prior to use.
Packages for smaller format medical devices are often made entirely of paperboard. Large format packages, however, require an amount of paperboard that is too great for practical use with products requiring a drying cycle. Thus, there is also a need for packaging utilizing a sufficient amount of paperboard that is supplemented with a second material that is less hydrophilic. There also remains a need for packaging that is easy to open so that the medical device stored therein may be easily accessed. Providing a package having this feature is especially challenging where the non-paperboard component is not as structurally supportive as the paperboard component.